NCT02436486已完成1 期
Interventional, Randomised, Double-blind, Placebo- and Positive Controlled, Single-dose, Cross-over Study Investigating the Effect of Idalopirdine on Cardiac Repolarisation in Healthy Men
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Change from pre-dose baseline in the QT interval (ΔQTcF) at each post-dose time point within the ECG collection period
研究概览
简要总结
To evaluate the effect of idalopirdine (120 and 360 mg) on cardiac repolarisation in healthy men.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body weight at least 50 kg and Body Mass index >18.5 and < 30 kg/m2
- •Good general health ascertained by a detailed medical history, laboratory tests and physical examination
- •Use of contraception.
排除标准
- •The subject has evidence of cardiac conduction abnormalities as calculated by the ECG equipment and evaluated by the investigator, at the Screening Visit or at the Baseline visit
- •The subject has a history of long QT syndrome, history of cardiac arrhythmia, or history of cardiac disease (eg, coronary artery disease, valvular disease, etc.).
- •Other protocol defined inclusion and exclusion criteria do apply
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Idalopirdine 120 mg
Experimental
Therapeutic dosages
干预措施: ldalopirdine 120 mg (Drug)
Idalopirdine 360 mg
Experimental
Supra-therapeutic dosages
干预措施: Idalopirdine 360 mg (Drug)
Moxifloxacin 400 mg
Active Comparator
Positive Control
干预措施: Moxifloxacin 400 mg (Drug)
结局指标
主要结局
Change from pre-dose baseline in the QT interval (ΔQTcF) at each post-dose time point within the ECG collection period
时间窗: For 24 hours in each dosing period
The QT interval will be corrected for heart rate by using the Fridericia's method (QTcF)
次要结局
未报告次要终点
研究者
研究点 (1)
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